Gianfranco Fornasini has played a major role in the SNDA submission for the approval of Carnitor� Injection in End-Stage Renal Disease patients undergoing dialysis. Dr. Fornasini's expertise entails pharmacokinetics and drug metabolism, specifically of endogenous substances, analytical methods with emphasis on mass-spectrometry, pharmacokinetic and bioequivalence study design, and regulatory and technical aspects of chemistry manufacturing and control processes. He joined Sigma-Tau Pharmaceuticals, Inc. in 1996 as Manager of Pharmacokinetics and Drug Metabolism and later became actively involved in the regulatory field. In 1998, Dr. Fornasini was promoted to Director of Regulatory Sciences and Pharmacokinetics. In 2001, he became Vice President of Regulatory Sciences, and in 2003, Senior Vice President of Scientific Affairs. Prior to joining Sigma-Tau, Dr. Fornasini worked for 9 years at the Zambon Group in Milan, Italy, holding several positions including Mass-Spectrometry Specialist, Preclinical Pharmacokinetics Researcher, Senior Researcher of Clinical Pharmacokinetics, and Head of the Pharmacokinetics and Drug Metabolism Department. Dr. Fornasini earned his doctorate in pharmaceutical chemistry and technology from the University of Milan, Italy and specialized in mass-spectrometry at the Laboratory of Pharmacology and Environmental Toxicology of the Istituto di Ricerche Farmacologiche M. Negri in Milan, Italy. He continued his studies at the University of Manchester, Manchester, United Kingdom, where he received his postdoctorate training in pharmacokinetics.